Sleep Disturbances in Hospitalized Children

Data for each participant will be collected from the medical records and will include: demographic data, gender, and clinical background. Underlying sleep disorders will be screened by an accepted and validated sleep questionnaire \[28\] (appendix A) The study will consist of 5 sequential and continual steps: step 1 - the week prior to admission to the hospital; step 2 - the night before surgery; step 3 - anesthesia and surgery; step 4 - the post operative hospital stay; step 5 - home, 2 weeks after discharge. Step 1: all 90 patients will undergo sleep evaluation by actigraphy and a sleep log (appendix B), for 7 days prior to surgery in their usual sleep environment at home. Step 2: the patients will be divided into 3 study groups in a double-blind, placebo-controlled randomization: 1. Thirty children will receive melatonin (Circadin) 2 mg, one hour before bedtime and will consist of study group A. 2. Thirty age, gender and disease matched controls will receive placebo and will consist of placebo group A. 3. Thirty age, gender and disease matched children will not receive anything (control group). Actigraphy and completion of sleep questionnaire will be also performed in hospital in the night prior to surgery. Step 3: stress assessment during anesthesia and surgery will be assessed by the following variables that are routinely monitored and recorded during surgery by the MDsoft computerized system: heart rate, blood pressure, end-tidal CO2, amount of anesthetic agents, opiate consumption. Step 4: actigraphy and completion of sleep questionnaire will be performed in each night of the post-surgery hospital stay period and up to 1 week post-surgery. Step 5: two weeks after discharge, an additional follow-up sleep log and actigraphy will be performed for 5 consecutive nights. Practically, children will be recruited in triplicates so that each triple will consist of the same gender, age and type of surgery. By randomization they will be assigned to one of each of the study groups. Post operatively, each pair of patients of study group A and the placebo group A (not including control group) will be randomly re-divided into two new groups: study group B - children who will receive melatonin every night and control group B who will receive placebo every night one hour before bedtime for the rest of the hospitalization. Sleep evaluation: Sleep will be evaluated by sleep log which is a diary of sleep variables completed by parents after each night (appendix B) and by actigraphy. Actigraphy An actigraph is a watch-like device that is placed on the wrist. It is a noninvasive continuous ambulatory measure used to objectively evaluate sleep. The use of actigraphy for both clinical and research purposes is well established. Actigraphy is a reliable and valid tool for detecting disturbed sleep and a useful technique for the evaluation of insomnia and circadian rhythm disorders \[10\]. It is an accepted and common technique in children \[29\] and is routinely used in our pediatric sleep clinic.